Autosomal dominant polycystic kidney disease (ADPKD)
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the preceding study (156-05-002) 2) Patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up.
Exclusion criteria
Exclusion criteria: 1) Patients with eGFR of less than 15 mL/min/1.73 m2 2) Patients with any of the following complications - Uncontrolled hypertension - Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis) 3) Patients with any of the following complications or history thereof - Clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity - Inability to personally give consent due to a mental illness 4) Patients with SBP (in sitting position) <90 mm Hg 5) Patients with a history of massive bleeding or bleeding tendency 6) Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination 7) Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant 8) Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061 9) Any patient who, in the opinion of the principle investigator or subinvestigators, should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: adverse events, pre-treatment adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG Every 4, 12, or 24 weeks Efficacy: combined renal volume (right and left kidneys) and renal function test Every 12 or 48 weeks | — |
Outcome results
None listed